US FDA approves Moderna’s RSV vaccine, its second marketed product

By Thomson Reuters May 31, 2024 | 10:06 AM

By Patrick Wingrove

(Reuters) – The U.S. Food and Drug Administration has approved Moderna’s respiratory syncytial virus (RSV) vaccine, the company announced on Friday, giving it a shot at much-needed new revenue from a second product.

Moderna’s vaccine was approved by the FDA for the prevention of RSV-associated lower respiratory tract disease in adults aged 60 or older.

RSV, which produces symptoms similar to a cold but can be fatal for young children and older adults, causes about 14,000 deaths annually in adults aged 65 and older.

The Cambridge, Massachusetts-based company has been banking on its experimental shots to make up for vastly lower demand for its Spikevax COVID-19 vaccine, its only marketed product.

Moderna’s RSV shot is the first messenger RNA-based (mRNA) vaccine not for COVID-19 to be approved in the United States. It will be sold under the brand name mRESVIA

The company has said mRNA vaccines, which teach the body to make specific proteins that the immune system can recognize and attack, have the potential to treat multiple diseases and be more effective than conventional shots.

“The FDA approval of our second product, mRESVIA, builds on the strength and versatility of our mRNA platform,” Moderna CEO Stephane Bancel said in a statement.

Analysts on average forecast sales for Moderna’s RSV vaccine of $340 million in 2024, growing to $830.5 million next year, according to LSEG data.

A panel of advisers at the U.S. Center for Disease Control and Prevention (CDC) will vote next month on recommendations for the vaccine’s use and intended population.

A positive decision from the agency will allow Moderna to compete in the U.S. fall vaccination campaign against market leader GSK and Pfizer, which has badly lagged its British rival since both launched their RSV shots last year.

GSK’s Arexvy is currently approved in the U.S. for adults aged 60 and over. British drugmaker has applied to extend the approved age group to include adults aged 50-59.

Pfizer’s Abrysvo is approved for adults aged 60 and older, as well as women at 32 through 36 weeks of pregnancy in order to protect their infants at birth.

Moderna filed for FDA approval on data from a late-stage trial that showed its vaccine was 83.7% effective at preventing at least two symptoms of RSV, such as cough and fever.

The company’s shares fell last February, after new data showed faster declines in the efficacy of its RSV vaccine when compared to the GSK and Pfizer shots.

(Reporting by Patrick Wingrove; Editing by Bill Berkrot)